Quality & Testing Standards
FDA-Registered Facility · cGTP Compliant (21 CFR Part 1271)
Quality & Testing Standards
Every lot we ship carries dual-lab COA documentation, NTA-verified particle counts, and a complete testing panel — because the practitioners we serve need verifiable data, not marketing claims.
Dual-Lab
COA Verification
7-Panel
Testing Standard
NTA
Particle Verified
Why It Matters
What Sets Our Testing Apart
Not every biologics supplier tests the same way. These four standards define how SNN verifies quality on every lot before it ships.
Dual-Lab COA Verification
Every lot is tested at two independent laboratories. The manufacturing lab runs initial quality-control panels, and an independent third-party lab runs confirmatory testing. Both reports ship with your order.
NTA Particle Verification
Nanoparticle Tracking Analysis (NTA) measures the actual size distribution and concentration of particles in every exosome lot — not estimated counts, but observed values with verifiable instrumentation data.
Published Testing Panels
Sterility, endotoxin, mycoplasma, viability, identity, and karyotype — all tested and documented on every lot. We publish what we test rather than asking practitioners to take our word for it.
Lot-Level Traceability
Every vial ships with a lot number that traces back to donor eligibility screening, tissue recovery, processing records, and testing results. Full chain of custody from source to delivery.
Dual-Lab Standard
How Our COA Process Works
Two independent labs. Two sets of results. One verifiable standard for every lot.
01
Manufacturing QC
The manufacturing laboratory runs in-process quality control testing during production — sterility, endotoxin, cell count, and viability assessments.
02
Independent Lab Testing
Samples from the same lot are sent to an independent third-party laboratory for confirmatory testing under separate controls and instrumentation.
03
Results Comparison
Both sets of results are compared. Any discrepancy between the manufacturing lab and independent lab triggers a hold-and-review before the lot is released.
04
Documentation Ships
Both COA reports ship with every order. Practitioners receive the manufacturing lab report and the independent lab report together for their own records.
Testing Panels
What We Test on Every Lot
Each product category carries a testing panel matched to its specifications. These are the core tests documented on every Certificate of Analysis.
Sterility Testing
14-day USP sterility testing for aerobic and anaerobic bacteria, fungi, and yeast. Both direct inoculation and membrane filtration methods.
USP <71> Protocol
Endotoxin Screening
Limulus Amebocyte Lysate (LAL) kinetic turbidimetric assay to quantify bacterial endotoxin levels and confirm they fall within acceptable limits.
USP <85> LAL Method
Mycoplasma Detection
PCR-based mycoplasma testing with sensitivity to detect contamination that traditional culture methods can miss. Negative result required for lot release.
PCR Amplification
Cell Viability (MSC)
Trypan blue exclusion assay documenting post-thaw viability percentage for UCT-MSC products. Our lots consistently document 95–97% viability post-thaw.
Trypan Blue Exclusion
Cell Identity Markers (MSC)
Flow cytometry analysis confirming positive expression of CD73, CD90, and CD105, with negative expression of hematopoietic markers per ISCT criteria.
Flow Cytometry
NTA Particle Count (Exosome)
Nanoparticle Tracking Analysis documenting particle size distribution and concentration per milliliter. Instrument-verified data, not extrapolated estimates.
NanoSight Instrumentation
Manufacturing
Facility & Processing Standards
Our products are processed at an FDA-registered, cGTP-compliant tissue establishment following 21 CFR Part 1271 requirements.
3D Bioreactor Culture
UCT-MSC products are expanded using 3D bioreactor culture systems rather than traditional 2D flask culture. 3D culture environments more closely replicate in-vivo conditions, supporting consistent population doublings and cell characteristics.
cGTP Compliant Facility
Processing follows current Good Tissue Practices under 21 CFR Part 1271. This includes environmental monitoring, equipment qualification, personnel training, standard operating procedures, and documented quality management systems.
Donor Eligibility Screening
All tissue sources undergo comprehensive donor eligibility determination including medical history review, social history assessment, and FDA-required communicable disease testing panels prior to tissue acceptance.
Logistics
Cold-Chain & Storage Standards
Product integrity depends on what happens after manufacturing. Our cold-chain standards maintain documented temperature control from the processing facility to your practice.
- Exosome products shipped frozen on dry ice via overnight carriers
- UCT-MSC products shipped in validated cryogenic packaging
- Temperature monitoring included in every shipment
- Insulated packaging validated for transit duration
- Storage and handling instructions included with every order
−80°C
Exosome Storage
LN₂
MSC Cryostorage
24hr
Overnight Shipping
Verified
Temp Monitoring
What Ships With Every Order
Documentation Included
Every order ships with complete documentation. These records are yours to maintain for practice compliance files.
Manufacturing Lab COA
In-process quality control results from the manufacturing facility including sterility, endotoxin, cell count, and viability data.
Independent Lab COA
Confirmatory test results from an independent third-party laboratory run on the same lot under separate instrumentation and controls.
NTA Report (Exosome)
Nanoparticle Tracking Analysis report showing particle size distribution and concentration data from NanoSight instrumentation.
Viability Report (MSC)
Post-thaw viability assessment documenting cell count and viability percentage verified by trypan blue exclusion assay.
Donor Eligibility Summary
Summary documentation confirming donor eligibility determination was completed in compliance with FDA requirements.
Handling & Storage Guide
Product-specific storage requirements, thawing instructions, and handling best practices for maintaining product integrity at your facility.
Common Questions
Quality & Testing FAQ
What does "dual-lab COA" mean?
It means every lot is tested at two independent laboratories — the manufacturing facility's quality-control lab and a separate third-party lab. Both sets of results are provided with your order so you can compare them independently rather than relying on a single source of testing data.
What is NTA and why does it matter for exosomes?
Nanoparticle Tracking Analysis (NTA) uses laser light scattering and video tracking to measure individual particles in suspension. It documents the actual particle concentration and size distribution in each lot. This is instrument-verified data — not extrapolated estimates from protein assays or other indirect methods. For exosome products, NTA provides the most direct measurement of what is in the vial.
How is 95–97% post-thaw viability verified?
Post-thaw viability for UCT-MSC products is assessed using trypan blue exclusion. A sample is thawed following the documented protocol and stained with trypan blue, which is taken up only by non-viable cells. The viable cell percentage is then counted and documented on the COA. Our lots consistently document 95–97% viability using this method.
What donor screening is performed?
All tissue sources undergo donor eligibility determination as required by FDA regulations. This includes a review of relevant medical and social history, as well as communicable disease testing panels. Only tissue from donors who meet all eligibility criteria is accepted for processing. Donor eligibility summary documentation is available with every order.
What does "FDA-registered facility" mean?
An FDA-registered tissue establishment has filed its registration and product listing with the FDA as required for entities that recover, process, store, or distribute human cells, tissues, and cellular and tissue-based products (HCT/Ps). Registration means the facility is listed in the FDA's database and subject to inspection. It does not mean individual products have received FDA approval or clearance.
Can I request documentation before placing an order?
Yes. Approved wholesale accounts can request sample COA documentation, NTA reports, and product specification sheets before placing their first order. Contact us through the wholesale application or reach out to our team directly.
Questions About Our Standards?
Request Documentation or
Apply for Wholesale Access
Approved accounts receive full COA documentation, NTA reports, and specification sheets with every order. Apply for wholesale access to review our testing standards firsthand.
Stem Nova Network is an FDA-registered tissue establishment operating under cGTP (21 CFR Part 1271). FDA registration does not imply FDA approval or endorsement of any product. All products are processed and distributed in compliance with applicable federal and state regulations. Documentation described on this page is provided for informational and compliance-record purposes.